THERAPEUTIC GOODS ACT 1989 - SECT 32BG Criminal offences and civil penalty relating to a failure to notify the Secretary about manufacturing
THERAPEUTIC GOODS ACT 1989 - SECT 32BG
Criminal offences and civil penalty relating to a failure to notify the Secretary about manufacturing(1) A person commits an offence if:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans; or
(iii) manufactures a biological in Australia for use in humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(1A) A person commits an offence if:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans; or
(iii) manufactures a biological in Australia for use in humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
(1B) An offence against subsection (1A) is an offence of strict liability.
Civil penalty
(2) A person contravenes this subsection if:
(i) imports a biological into Australia for use in humans; or
(ii) exports a biological from Australia for use in humans; or
(iii) manufactures a biological in Australia for use in humans; or
(iv) supplies a biological in Australia for use in humans; and
(b) the person is the sponsor of the biological; and
(c) the person is not exempt under subsection 32CA(1) in relation to the biological and the biological is not exempt under subsection 32CA(2); and
(d) the person has not, at or before the time of the importation, exportation, manufacture or supply, properly notified to the Secretary either or both of the following:
(i) the manufacturer of the biological;
(ii) the premises used in the manufacture of the biological.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
(3) For the purposes of this section:
(a) a manufacturer is properly notified to the Secretary if:
(i) the manufacturer was nominated, as a manufacturer of the biological, in an application for inclusion of the biological in the Register; or
(ii) the Secretary was subsequently informed in writing that the manufacturer is a manufacturer of the biological; and
(b) premises are properly notified to the Secretary if:
(i) the premises were nominated, as premises used in the manufacture of the biological, in an application for inclusion of the biological in the Register; or
(ii) the Secretary was subsequently informed in writing that the
premises are used in the manufacture of the biological.